Human Allergy Catalog - Greer

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The initial dose of the extract may be as low as 0.1 mL of a 0.005 to 0.05BAU/mL dilution (0.0005 to 0.005 BAU) (dilution 5 or 6 in TABLE 4 below) oreven less for the exquisitely sensitive patient. Patients with lesser sensitivity maybe started at 0.1 mL of a 0.5 to 5 BAU/mL dilution (0.05 to 0.5 BAU).The amount of allergenic extract is increased at each injection by no more than50% of the previous amount, and the next increment is governed by the responseto the last injection. Large local reactions which persist for longer than 24 hoursare generally considered an indication for repeating the previous dose or reducingthe dose at the next administration. Any evidence of systemic reaction is anindication for a reduction of 75% in the subsequent dose. The upper limits ofdosage in BAU have not been established. Doses larger than 0.2 mL of an extractin 50% glycerin may cause discomfort upon injection. The dosages of allergenicextracts do not vary significantly with the allergic disease under treatment.To prepare dilutions starting from a 100,000 BAU/mL concentrate, proceed as inTABLE 4. The 50,000 BAU/mL concentrate can be made by using equal parts ofthe 100,000 BAU/mL extract and the sterile diluent. The ten-fold dilution seriesuses 0.5 mL of concentrate to 4.5 mL of sterile diluent with additionaldilutions made in the same manner.TABLE 4Ten-Fold Dilution Series*Dilution Extract Diluent BAU/mL BAU/mL0 Concentrate 100,000 10,0001 0.5 mL concentrate 4.5 mL 10,000 1,0002 0.5 mL dilution 1 4.5 mL 1,000 1003 0.5 mL dilution 2 4.5 mL 100 104 0.5 mL dilution 3 4.5 mL 10 15 0.5 mL dilution 4 4.5 mL 1 0.16 0.5 mL dilution 5 4.5 mL 0.1 0.01*Due to differences such as source material, preservative, potency dilutions,storage conditions, and length of storage, there is no common potency correlationratio between extracts standardized in Bioequivalent Allergy Units (BAU) and: 1)standardized extracts previously labeled in Allergy Units (AU); 2) nonstandardizedextracts labeled weight-to-volume (w/v); 3) nonstandardized extracts labeledin Protein Nitrogen Units (PNU); or 4) alum-precipitated extracts.The optimal interval between doses of allergenic extracts has not been established.Injections usually are given 1 or 2 times per week until the maintenance dose isreached. The injection interval is then increased to 2 weeks, then to 3 weeks andfinally to 4 weeks. If the patient does not return for 6 to 8 weeks, the dose shouldbe reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction ofone, two or three dilutions may be made considering the components and thepatient’s sensitivity. The dosage and the interval between injections may need tobe modified according to the clinical response of the patient. When switchingpatients to fresh extract, the initial dose should be reduced to 25% of theprevious dose.13
The usual duration of treatment has not been established. A period of two orthree years of injection therapy constitutes an average minimum course oftreatment.Parenteral drug products should be inspected visually for particulate matter anddiscoloration prior to administration, whenever solution and container permit.Some concentrated extracts naturally develop a cloudy appearance over timeunder refrigeration, the material settling to the bottom on standing.HOW SUPPLIEDStock concentrate extracts containing 10,000 BAU/mL and 100,000 BAU/mLare supplied in 10, 30 and 50 mL multiple-dose vials in 50% glycerin.(Standardized Bermuda grass pollen extract is supplied at a maximum strength of10,000 BAU/mL.) Extracts for puncture, prick or scratch testing are supplied in5 mL dropper vials at 10,000 BAU/mL or in multiple-dose vials at 100,000BAU/mL (except Bermuda) in 50% glycerin. Intradermal strengths shouldbe prepared by dilution of stock concentrates with normal saline or salinecontaining HSA.STORAGEAll allergenic extracts should be stored at 2-8°C and kept in this temperaturerange during office use. Refer to vial labels for expiration dates. Clinicians shouldbe aware that diluted extracts are inherently less stable than concentrates.Dilutions of glycerinated extracts which result in glycerin below 50% may alsobe less stable. Potency of a particular dilution can be checked by skin test incomparison to a fresh dilution of the extract on an individual known to beallergic to the specific antigen.REFERENCES1 Turkeltaub, P.C., Rastogi, S.C., Baer, H., Anderson, M.C., Norman, P.S.:A standardized quantitative skin-test assay of allergen potency and stability:Studies on the allergen dose-response curve and effect of wheal, erythema,and patient selection on assay results. J. Allergy Clin. Immunol. 1982;70:343-352.2 ELISA competition assay. Methods of the Allergenic Products TestingLaboratory, Laboratory of Immunobiochemistry, Division of AllergenicProducts and Parasitology, Center for Biologics Evaluation and Research,Food and Drug Administration, 1401 Rockville Pike, Rockville, MD20852-1448, 1994.3 Turkeltaub, P.C., Rastogi, S.C.: Quantitative intradermal procedure for evaluationof subject sensitivity to standardized allergenic extracts and for assignment ofbioequivalent allergy units to reference preparations. Ibid.4 Turkeltaub, P.C.: Assignment of bioequivalent allergy units based on biologicalstandardization methods. Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt furSera und Impfstoffe), Band 52, Gustav Fischer Verlag, Stuttgart-New York, 1988.5 Lichtenstein, L.M., Ishizaka, K., Norman, P.S., et al.: IgE antibody measurementsin ragweed hay fever: relationship to clinical severity and the results ofimmunotherapy. J. Clin. Invest. 1973;52:472.14
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